Qa Reviewer

The Quality Assurance (QA) Reviewer plays a pivotal role in ensuring the integrity and compliance of investigations into deviations encountered during pharmaceutical manufacturing processes. This position requires meticulous attention to detail, strong technical writing skills, and adherence to regulatory standards and company procedures.

• Conduct thorough reviews of deviation investigations, encompassing minor, major, and critical incidents, to ensure compliance with established quality standards and regulatory requirements.
• Utilize technical writing skills to accurately document investigation findings and follow scientifically sound approaches throughout the investigation process.
• Review to ensure the completeness and accuracy of investigation reports by addressing the following aspects:
• Clearly define the investigation problem statement with a concise and specific description.
• Identify the scope of the investigation, including the lots, batches, or systems impacted.
• Assess the adequacy of deviation assessment, incorporating relevant data, test results, and supporting documents.
• Verify that immediate actions taken are aligned with the initial assessment of the deviation.
• Evaluate the adequacy of root cause analysis, considering relevant data, records, test results, and supporting information.
• Conduct a final impact assessment to determine the extent of the deviation's impact on product quality and compliance.
• Develop corrective and preventive actions (CAPAs) aligned with identified root causes.
• Verify the effectiveness of CAPAs through rigorous evaluation and verification.
• Ensure that the investigation report is comprehensive, self-sustaining, and conclusive.
• Adhere strictly to site procedures and comply with client requirements for all investigations, maintaining the highest standards of quality and integrity.
• Include legible and accurate supporting documents for each investigation, ensuring they provide clear evidence and support the investigation findings during revisions.
• Communicate any encountered roadblocks during the revision promptly and escalate issues to the supervisor as necessary to ensure timely resolution.
• Work on-site and collaborate effectively as both a team member and an individual contributor, fostering a culture of quality and continuous improvement.